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DOES THE SOURCE, MEASUREMENT, DOSE, BALANCE, and ROUTE OF ADMINISTRATION OF HRT MATTER? 3. THE IMPORTANCE OF THE ROUTE OF HRT?

July 20, 2008 · No Comments

Ross & Henderson’s sentinel (JAMA 1980) paper on the strong relationship between long term oral premarin  total dose and breast cancer was  largely ignored:  that  with cumulative premarin dose >1,500 mg (ie 7yrs) the breast cancer  risk  was estimated to be 2.5 in women with ovaries (vs  0,7 sans ovaries); the risk ratio for a high cumulative dose (ie after about 15years, >3mg premarin)  rose to 5.7 relative to nonusers with normal breasts.

 

But at the same time, Finnish papers in Maturitas showed why, because of non-physiological high E1>E2 even on oral E2,  systemic ERT is preferred:

Punnonen R ea: (in E2V 2mg/d  & the Renin-Aldost system: 1980:2:91-4) that  “on oral E2v the E2 levels rose to normal and (unlike  on oral premarin, EE2) caused  no rise In BP, aldost, renin; they thus preferred such natural  ERT which does not activate the biliary, RAS renin-angiotensin system, and thrombosis”;

 but Heinonen  PK et al (1982:4: 273-6 Estrogen levels on oral E2) showed that  on E2v  4mg/d orally, blood   E2 rose 5X and  E1 rose 25X; so they recommended avoiding   oral ERT.

 

Thus the Womens’ Health Initiative confirmed three facts: 

1. starting OHT well after age 60yrs and continuing even modest dose cyclic  (premarin 0.625mg plus MPA 5mg) does more harm than good; THIS SAYS NOTHING ABOUT APPROPRIATE PHYSIOLOGICAL BALANCED COMBINED PARENTERAL TESTOSTERONE-PROGESTERONE-ESTRADIOL HRT FROM ANY POSTMENOPAUSAL AGE HAVING ANY  LIFELONG RISKS WHATSOEVER.

  

2. starting the same OHT regime soon after menopause - especially premarin alone- reduces  all major diseases and mortality by about a third, except for rare cases of deep vein thrombosis and cholelithiasis;  this outcome was confirmed in the 9year RCT in Finland (Heikkinen ea 2006) in which women on oral estradiol 1mg/d +- MPA 2.5mg from menopause had zero major adverse events.  BUT THIS SPEAKS ONLY FOR AT MOST THE 9 YEARS THAT  THESE WOMEN WERE IN THE TRIALS.

 

There are  so far some seven  major functional types of steroid hormones  in humans: calciferols; androgens; estrogens; progestins; glucocorticoids; mineralocorticoids; and  endogenous digitalis- natriuretic hormone (eg Goldstein  2006, Weidemann 2005; Kurup ea 2003) .

     Apart from  gender-reproduction-childhood growth promotion (ie androgens, estrogens & progestins), their actions fall into many other systemic classes; which in conventional “replacement” doses  the literature and experience suggests may be compared as follows:

 

 

Muscle anab-olic

Body

fat  gain

Bone spar- ing

Mineralocor-ticoid

Immuno-enhancing

cancer prom-oting

Infec- tion risk

Mood & mind

1 Calciferols

+

 

+

+

modulating

-

-

+

2 TT, DHEA

+

inner

++

+

modulating

-

-

+++

3 Estradiol E2

- (or n)

outer

+

+

enhancing

+

-

+

4 progestin

N

n

n

+

modulating

-

-

++

5 Cortisones

-

+

-

+

suppressive

-

+

+

6 aldosterone

-

 

-

++

 

?n

?n

-

7 Digoxin

+ heart

? -

+

Anti-

-

+

-

Anti-

synthetic E;       

 E1, E3,

-

+

+

++

++

++

-

+

Oral AS

+

inner

++

++

modulating

+

 

+++

+=increase;    - = lessen; n = apparently neutral?  AS=anabolic steroids.

 

The active hydroxycalciferols are in a sense exocrine ie are produced from ingested  vitamin D3 and cholesterol in the skin and kidneys, not from dedicated endocrine glands; but while their synthesis needs no more than an hour of sunlight a week in sunny climates, and modest kidney function, calciferol deficiency is increasingly recognized in those who take little dairy products, and little sunshine. Thus the pituitary, skin,  parathyroids, adrenals  and  gonads are the primary  endocrine glands of growth.

 

The other steroid hormones (like the other major anabolic hormones- insulin and human growth hormone HGH) are endocrine ie are vulnerable to both intrinsic endocrine failure (Hypothalamic-Pituitary-Adrenal- pancreatic-Gonadal ),  and to  endocrine gland decrease and blockage by infections, cancer, major stress, auto-antibodies or direct trauma.

 

       All these anabolic  hormones  if swallowed are destroyed  by digestion/  1st-pass hepatic metabolism; thus to achieve the same systemic effect,   comparative doses are reported as follows:                 

 

     ORAL-hepatic

    PARENTERAL

TT men            

     women

   120mg/day      

     5-10mg/day

   7-10mg/day   

    0.5-1mg/d

Estradiol

    1-2mg/d

   0.03-0.1mg/d

progesterone

    5-10mg/d

   0.15-0.3mg/d

Cortisone acetate

    25-50mg/day

   2-5mg/day

fluodrocortone

    0.1-0.2mg/d

   0.01-.02mg/d?

HGH

  autodigested

  +- 0.1mg/kg/wk

insulin

  autodigested

  ~40u/day

 

The vulnerability  of oral steroid therapy is illustrated by oral contraception: where taking eg an oral antibiotic can compete for absorption, reducing   blood SH levels so that accidental conception occurs. Similarly, a postmenopausal  patient with rheumatoid arthritis, on oral (E+P HRT), reports that  her analgesic  requirements  rise while she is on antibiotics.

     

     One  needs to go back to a standard textbook of Pharmacology of  1958, (Kranz & Carr: Pharmacological Principles of Medical Practice: Balliere, London) to find the corollary:  eg “cortisone acetate implant, or im  2-5mg daily injection as replacement for  Addisons’ Syndrome”: “For menopausal symptoms, combined E+TT is often employed…”;  “oral synthetic estrogens (have replaced natural ones due to availability,  oral form & lower cost; but) produce undesirable: nausea, cramps, migraine and male breasts.    Estrogen + TT are additive, and E doses may therefore be reduced   since the combination gives smoother transition:  73% of patients remain  symptom free.    TT 10mg imi 3 x/week may control  functional uterine bleeding better than progesterone”!.

      It is widely overlooked that  TT is converted irreversibly by aromatase to E2 in the tissues; but   giving E2 does not do the reverse – it  suppresses the  HPAG and   TT production. Thus women need to be given TT with estrogen, but  men do not need to be given estrogen -  giving them TT increases their E2 levels by about 1/3. This source of E2 may not be enough for balance in women, but reduces their needed dose of administered estrogen;  hence in women  on a standard 20:1 TT:E2  injection combination, or on combined implants eg TT 50mg + E2  20mg/6months,  the blood TT level should be monitored to check that the mean TT is in the physiological range of  1-3.5nmol/L, but the E2 level need  not be above perhaps 0.1nmol/L – in fact, to avoid excess fat deposition and breast cancer stimulation, it must  not , since TT is supplying E2 direct in target organs.

     Hence Ginsberg J & Prevelic GM  at Royal Free Medical School  ( Drug Therapy & Reproductive Endocrinology: London: Arnold 1996) note that in BRCA, androgen + prednisone give good results;  they advise: parenteral> oral ERT: eg  E2 patch 50u/d;  or Implants eg TT 50mg + 20mg E2 /6mo (= 300mcg TT + 110mcg E2/ day)..

 

In TOPICS IN O & G 1998: (ed Julian Bassin: Julmar Communications, Jbg 4th Ed 1998: sponsored by all the RSA gyne Drug Suppliers):  Schnitzler CM wrote that “ERT should be given for life, from as early as possible, but even from 80yrs; the elderly not exposed to the sun needing >2000u vit D/day. Sonnendeker on HRT wrote that oral  HRT raises both coagulation & renin substrates acutely; EE2 should not be used for ERT; thus he prefers oral ERT except  if coagulopathy, liver/biliary/ triglyceride/ or vascular headache  problems, when he uses non-oral ERT. Indications for androgens are: poor libido; persistent tiredness & OP; preferring the 25mg TT pellet to oral androgens or imi esters”.

 

Finally, the physiological logic of parenteral  (as opposed to oral) HRT- in this case sex hormone replacement) was already well recognized and marketed over 60 years ago – even in South Africa- in eg the handbook Sex Endocrinology (Schering, New Jersey, 1944) which recommended and listed creams, injections and implants as well as tablets.

 

William Masters and colleagues followed this up with the first apparent RCT of HRT published in 1953,  who showing  in a 13month titration RCT that biweekly ie shortacting  esters  imi TT 20mg  + E2 1mg    (= T ~2.8mg/d + E2 ~0.14mg/d, ie a ratio of 20:1 to 22:1 – as in Schering’s Primodian Depot or Organon’s Mixogen)  restored 70% of geriatric women in their mid70s to selfcare; allowing the nursing staff on the unit to be halved. Overall the women had ~one brief menstrual bleed  after about 5weeks, thereafter on follow-up biopsy all maintained endometrial atrophy. Some  needed initial T:E dose titration (between eg 30:1 to 15:1)  for individual variation in response. As a result  both Schering and Organon to this day sell this preparation as a 100mg TT ester + 5mg estradiol ester ial, to be given as desired every 3 – 6 weeks.

     We have found for the past  ~10 years that, just as hypogonadal men do optimally  on about 200mg depotrone subcutaneously sc  every fortnight (= 10mg TT a day), women do well on  Masters’  20:1  TT:E2 hormone ratio, the optimal regime being on average 0.2ml 20mg of hormones by domestic  subcutaneous selfinjection every 2 weeks ie TT 1mg/day and E2  0.05mg/day,  – the average resultant  blood levels being TT round 2.5nmol/L - but of course the testosterone itself delivering far more estradiol extra- and intracellularly.

 

  With this regime we have never seen a breakthrough bleed in postmenopausal women, for the simple reason that follow-up endometrial ultrasound uniformly shows endometrial atrophy. We have also never seen increasing changes on follow-up screening mammography since it is common cause that testosterone suppresses female glandular breast proliferation.  

 

These  results with arenteral HRT  have been abundantly confirmed in women followed for up to  40years on parenteral HRT by leading menopause clinics such as Greenblat  & Ganbrell(Augusta); Gelfand(Montreal); Schiff(Boston), Buster(Houston), Notelovitz (Florida), Vliet(Tucson), Lichten(Michigan), Shippen(Philadelphia), Karpas(Atlanta); Schleyer-Saunders, Whitehead and Studd(London UK); Tvedegard Moller & Hansen(Copenhagen); Burger & Davis, Zhou & Dimitrikakis (Australia); and our Cape Town group under Davey;

and

most important of all:  since longterm trials beyond the necessary critical 20 years  will never be carried out in humans due to the cost, the results of primate studies by Thomas Clarkson ea at Wake  Forrest University  showing  that starting even oral premarin at castration in young  female monkeys and continuing it for the human equivalent of 15 years blocked onset of atheromatous disease ; but premarin alone or with MPA  produced breast proliferation;  but like endometrial proliferation, this was suppressed by testosterone replacement.

       The greatest myth (if not drug industry  hoax) of the past 30 years may be the claim that postmenopausal women (or for that matter women needing contraception) need a patent estrogen and a synthetic progestin for endometrial  and breast protection and contraception; when it was shown decades ago that depot estradiol plus depot progesterone- or better still,  depot estradiol plus depot  testosterone plus depot progesterone - do best for both contraception and HRT  and all-system protection against all the degenerative diseases of aging. 

 

The fevent hope and effort  of the patent designer drug industry is that they can buy off enough practitioners, academics, researchers, Regulators and politicians so that the widespread avilability, low cost - and massive all-disease prevention- of such natural supplements as human hormones as well as the dozens of other proven biologicals including vitamins and mineral is never appreciated and utiized. They cannot curb their insatiable lust   for immediate endless profits no matter how much suffering it causes - disaster capitalsm- by recognizing that if they now promote such safe cheap proven panaceas to both the poor and the prosperous consumers, they will extend healthspan by decades, producing far more survivors who will later rather than sooner still need/want to buy their designer products.

 

4. to follow: THE IMPORTANCE OF THE SITE OF PARENTERAL INJECTIONS

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COMMENT ON ROUTINE HIGH-TECH SCREENING JUSTIFICATION 20 APRIL 2008

July 14, 2008 · No Comments

See Drs Jeff Dach / Leonard Berlin’s comments on screening mammography.

http://www.jeffreydach.com | jdach@bellsouth.net | 65.2.47.69

Limitations of Screening Mammography

An eminent radiologist, Leonard Berlin MD says we have failed to disclose the limitations of screening mammography, namely that mammography will miss 30-70% of breast cancers, and leads to over diagnosis and over treatment.

Dr. Berlin says disclosures of these limitations should be mandated, just like the cigarette and drug warnings that appear on their ads.

Dr. Berlin also points out that 57% of the American women believe that mammograms prevent breast cancer, a misleading message from Breast Awareness Month.

Mammograms are designed to detect cancer, not prevent it. Thinking that a mammogram can prevent breast cancer is like thinking that checking your house annually for broken windows prevents robberies.

To read more: http://jeffreydach.com/2007/11/04/the-untold-message-of-breast-cancer-awareness-month.aspx

The Untold Message of Breast Cancer Awareness Month by Jeffrey Dach MD

Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood Fl 33021
954 983 1443
http://www.drdach.com
http://www.jeffreydach.com
http://www.naturalmedicine101.com

Categories: Uncategorized

COMMENTARY: NECESSARY SUPPLEMENTS vs THE RATH COURT JUDGEMENT

June 15, 2008 · No Comments

 NUTRICEUTICALS AND THE RATH  COURT JUDGEMENT

The context and background of the South African Cape Supreme Court judgement  of 13 May 2008 against the  Dr Matthias Rath Foundation (see the BBC article) and the South African ANC Government Ministry of Health , to stop illegal trials of vitamins in AIDS patients, is already concisely summed up in the updated Wikipedia Rath report of the same date, and the TAC report, and the self-damaging hard sell by the Rath Foundation itself.

 

To what extent the Rath group was conducting research trials as opposed to simply collecting feedback in a structured format becomes irrelevant when Rath websites and supporters manifestly urged patients not to take antimicrobials. It is epidemiogical bedrock that the inital study that leads to an hypothesis, and thus application for trials, permission and funding, is always observational - collation  and validation of data in the field. Provided confidentiality is maintained, and no intervention has been designed, no-one needs  ethical permission to collate and report data ethically collected from, for example, consumers or patients.  See this report by the National Ethics Advisory Committee (New Zealand) which proposes that ethical permission  is essential only for research purposes, but  is not necessary for observational study for audit or public health purpose.

 

What these reports do not clarify is the human background:

 

I saw just such a patient just before that judgement was given - a gaunt young middle-aged  Bantu factory owner whose wife has just had another baby, although the couple has recently become HIV positive.

Last year (when he was still HIV negative but lymphopaenic), his non-specific Reiter’s-type arthralgia after antibiotics settled on supplements; but since he stopped taking micronutrient supplements a month ago (already knowing he was HIV positive), he has develloped mouth sores, related cervical/ axillary adenopathy and now progressive dry cough and haemoptysis. Clinically he was still well, with chest clear clinically. This in a  family in townships where highly resistant TB has mushroomed. He came back for more supplements. He and his wife were firmly instructed to go for urgent TB screening, CD4 count, viral load and  appropriate antimicrobials, starting in the meantime with some nutritional immune supplement.

 

What more can one do in a ”democratic”  society where TB obviously cannot be notified without good evidence, and HIV-AIDS  is apparently still not a compulsorily notifiable disease ante mortem?

 

The diet of the poor or the ignorant - sugar, low nutritional value food,  and often smoking,  excess alcohol and stress, poor living/work  conditions, and lack of exercise -  often with little or no restful  sleep, fresh air, fresh produce or fish - promotes both infections and chronic degenerative disease, such as cancer,  diabetic- vascular, mental, arthritis and osteoporosis, because  such  lifestyle and  stressed aging creatures  are  deficient, imbalanced  in essential protective antioxidant  immunomodulating  anabolic  vitamins minerals and biologicals  eg  marine fatty acids, co-Q10, acetylcysteine, carnitine, hormones  and scores others.

 

It is common cause that the exhausted depleted body is far less able to prevent and  fight disease than the healthy are, whether against common colds or tuberculosis and cancer. One has only to think of  fever blisters, shingles, tuberculosis,  hypertension  or heart attack that are more prevalent in the stressed and nutritionally imbalanced;  and the fact that  the seriously ill are admitted to hospitals or sanatoria  - or given both food packages and drugs- for both balanced diet and modern therapy.

 

It is common cause - amongst sensible natural healers (sangomas), homeopaths and naturopaths as well as the medically qualified -  that it is folly to ignore antibiotics or modern therapies/ surgery with serious diseases where these are known to be responsive to antimicrobials, chemo-and radiotherapy. While designer modern synthetic antimicrobial, anticancer and anticardiovascular disease therapy may have major adverse effects, there is no contesting that they have major benefits in acute illness, especially when combined with appropriate macro- and micro-nutrition.

 

Drastic  modern high-tech  therapies are also   futile, unlikely to prolong life long  if underlying major malnutrition- obesity  with micronutrient imbalance, or starvation- are not simultaneously addressed. And designer drug companies are well aware that prescription drugs need to be supplemented where appropriate eg Viagra with testosterone, statins with CoQ10, anti-diabetics with alpha-lpoic acid , antibiotics with vitamins and pre/probiotics, NSAIDs with gastroprotectives  etc.

For cancer the evidence is comprehensively summed up at: Dietary Supplements in Patients With Cancer: Risks and Key Concepts, Part 2 Laura Boehnke Michaud, Julie Phillips Karpinski, Kellie L. Jones and Janet Espirito: Am J Health-Syst Pharm.  2007;64:467-480. 

For evidence in a broader context:    see  2008 Harvard Special Report on “Vitamins and Minerals: What you need to know.”

The South African Academy of Science recently released a massive three year  literature search report focusing on the controversy around  HIV, TB and nutrition, affirming that   “no component of food has yet been identified in any credible scientific study as being an effective substitute for appropriate antimicrobial agents when indicated for the treatment of HIV  or active tuberculosis infection. This does not in any way imply, however, that nutritional intervention has no role in the integrated management of these infections, especially in developing countries where nutritional deficiencies are also rife. “.
     Modern science  (funded mostly  by investors, entrepeneurs - not often by altruistic billionaires) has been slow, reluctant  to validate by scientific trials  the difficult-to-disprove  therapies that Linus Pauling  (and even Hahnemann and Rudolph Steiner) and  their  students promote(d) .

 

In particular, major studies from Toronto Canada,  and  Harvard University- Dar es Salaam Tanzania,   in 2006 showed striking  2 to 3 fold reductions in mortality from HIV and TB when ANTIMICROBIALS were supplemented with especially betacarotene  120  000 iu/day or zinc 45mg/day , let alone  iron, selenium, vitamin C,  D  and E,  amongst other minerals and vitamins  in both endemically deprived patients (Tanzania)  and western patients (Canada). 

 

In progressive  adult diseases like smoking  or alcoholism damage, overweight, diabetes  TB, HIV,  or  hypertension, it is folly, negligence not to diagnose and comprehensively treat early, whether just with lifestyle , or metformin or antimicrobials  or antihypertensives respectively. 

 

So the outcry against those who publically oppose all patented antimicrobial drugs  for eg HIV   is valid.  But as the Academy of Science has pronounced, this is not to  condemn prescription and provision of  good nutrition and proven appropriate natural  therapeutic supplements - which are  the original and often still the best medicines.

       The Cape Court judgement so far published carefully does not venture into this well-proven scientific area - nor pronounce judgement against the current Government  under  the ANC’s Presidents Mbeki and Zuma for it’s progressive impoverishment  and (by default of adequate funding and control of the police) permitted terrorization of the masses the past decade in favour of useless weapons, institutionalized  corruption and violence, and massive enrichment of the favoured bureaucrats and cadres as in Zimbabwe.. (lest it be forgotten, Mr Zuma was deputy president of South Africa from 1998 to 2004 ie from  when the  infinitely corrupt and avoidable Armsgate,  Eskom  and South African Airways insolvency disasters were forced  by the ANC Govt  on South Africa against massive public protests, that have ruined South  and thus southern Africa.).

“The Cape court did not find that Rath’s distribution of his products was unlawful merely because they are distributed. What was deemed to be unlawful were the claims  made in advertisements associated with Rath’s product distribution, i.e. the claims that rendered VitaCell a medicine. The court therefore interdicted the Rath respondents from making claims that VitaCell reverses the course of AIDS. http://www.tac.org.za/community/node/2348

     In reaching a decision on the second question, whether Rath and his accomplices were found to have conducted unauthorised clinical trials, the Court ventured into new legal terrain because “the term ‘clinical trial’ has never been judicially considered in South Africa” (para 72). In the absence of relevant South African case law, the Court considered a 2002 decision of the Zimbabwean Supreme Court where “clinical trial” was defined as:  “a systematic study in human beings or animals to establish the efficacy of, or to discover or verify the effects or adverse reactions of drugs”     

http://www.tac.org.za/community/node/2348. Importance of the judgment   “Many people in South Africa still present far too late to the public health system, with advanced AIDS. Many patients try all kinds of alternative remedies before finally seeking help from their local clinics. Many never take the opportunity to live longer, healthier lives by using scientifically proven antiretroviral medicines because they are hoodwinked into trying unproven elixirs. Charlatans and quacks abound; some of the more notorious  claim garlic , Ozone Rectal Therapy, and an African potato solution treat numerous diseases.  The Minister of Health has fostered this situation by creating the illusion that people with HIV have a reasonable choice to make between antiretrovirals versus alternative remedies and by failing to enforce the Medicines Act.   Charlatans operate in every society, but they usually operate on the fringes. In South Africa, charlatanism has become mainstream. This judgment has unequivocally established that the Minister of Health has a duty to enforce the Medicines Act and to uphold the scientific governance of medicine. “

ndb.

Some other  references: (more…)

Categories: cancer · supplements
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UPDATES: HEALTHY LIVING

June 13, 2008 · No Comments

We have just updated the blog with the latest detailed pharmacological information on the ingredients of our anti-aging powders, the powder blend compositions, and the mail-order/wholesale price lists.

These are all available on the page Product Details and Pricelists.

For information contact +27 741 LIFESPAN (0741 543377).

The public, as well as interested distributors/retailers, are invited to contact Healthspan Life!.

Categories: Uncategorized

CRIES OF INFECTION WOLVES, AND OFFICIAL ONGOING DENIAL OF NECESSARY PREVENTION:

April 27, 2008 · 1 Comment

It’s tragicomedy that the BBC – the quintessential British spokespersona – laments NHS woes: * UK c.diff deaths ‘rising sharply’ * “The equivalent of one person an hour dies in hospital from clostridium difficile, figures suggest.”

And yet Authorities there and mostwhere are still in denial about enforcing simple safe low-cost multi-system prevention – in this instance to keep people out of bed and hospital, off antibiotics.
Authorities- regulators, politicians, the Tax Man – benefit as hugely from disease as do their fairy godmother the Disease Industry- the Drug conglomerates and their researchers and lobbyists, private hospitals, medical schemes - that pay them handsomely and creates myriad factories and jobs.

So because it is not profitable, Prevention Does Not Pay, no matter that it adds decades to health:

*There is no move to ban smoking, to make it (and sale, and allowance thereof) a criminal offence.

*No move to immediately jail drunken drivers for a long time, and on second offence permanently confiscate their driving licence and ban them permanently from current and future public office and public vehicle driving, be they judges or janitors, cabinet ministers or cabbies.

*The banning of deadly polluting coal-and oil-powered vehicles and major electricity sources has been blocked for decades by the endlessly greedy and ruthless oil-based industry magnates, despite the fact that these finite energy sources are desperately needed for other purposes. Now the world faces immediate famine because the oil-based transport-and energy behemoths (who have blocked investment in natural – solar - energy for decades) are paying bigger dollars for crop and marine resources as energy supplies than most consumers can afford to pay for these finite resources as food.

*No official move to acknowledge that the best drugs for both prevention and chronic treatment are the long-proven natural low-cost vigorous safe daily doses of a few score appropriate micronutrient supplements - vitamins (~15), minerals(~10) and biologicals (human and other species’) that are increasingly inadequate in the food chain in longer-lived increasingly overweight stressed humans facing worsening man-made epidemics and environmental disaster.

*No serious move yet by the US FDA- the chief protector of the new drugs industry of the west -English- Europe- Japan – (against the interests of consumers) to enforce integrity, insist that no chronic designer drugs for the chronic major common degenerative diseases be released for general use until they have been proven both at least as safe and effective as those already existing and effective, in major randomised controlled trials of a mean of at least 8years, head to head against both older designer drugs, and long-proven natural drugs, for similar purpose, in those diseases.

*The past decade alone has seen condemnation of myriad unproven unnecessary and risky released drugs –
on Wikipedia alone at least a dozen - eg Propulsid; cerivastatin; Vioxx; pemoline; benzbromarone; torcetrapib; and the discrediting of the non-steroidal anti-inflammatory drugs as no better - and potentially more hazardous than- appropriate cortisone and micronutrient use, and
newer designer antidepressants and anticlotting agents as less safe and effective than appropriately used older ones;

*the unnecessary anti-osteoporosis bisphosphonates that are increasingly associated with the very long-bone fractures they are supposed to prevent;

*and most especially the wannabe oral anti-diabetic anti-atheroma and anti-obesity drugs – statins, rimonabant, glitazones, meglitanides and sulphonylureas - as inferior to and less safe than metformin, the 85year old plant extract which is the only designer drug ever proven as invaluable panacea in a 20year RCT, tested against sulphonylureas, but not against all other modern designer drugs which (as in more recent studies) have never been shown to meaningfully reduce all-cause morbidity and mortality as does metformin.

The until-recent FDA haste to licence new drugs after scanty trials was reminiscent of the criminal conspiracy between the FDA and industry that licenced the already contested diethylstilbestrol Chicago trial of 1950- and kept that drug on the market another 25years after it was discredited. And it was in stark contrast to the FDA (to protect USA drug companies) blocking drugs already in highly effective use elsewhere for decades, like lithium carbonate, metformin and betablockers.

Since no drug corporations promote the out-of-patent old and proven agents, authorities cannot afford to promote truth - that the only remedies for chronic prevention that lower all-cause disease and mortality by between a third and a half - overweight, obesity, diabetes, cancer, hypertension, arthritis, osteoporosis fractures, vascular disease, acute infections, depression, dementia - are:

-fish oil a few grams a day- which also drastically lowers behavioural and learning disorders;
-a lowcost simple blend of a few score other proven natural micronutrients - the fifteen vitamins, ten minerals and the human / other species’ biologicals including herbs;
-metformin titrated to tolerance about 2.5gms a day, for both prevention and treatment of overweight, diabetes type 2 and most major chronic degenerative diseases; &
-appropriate conservative balanced sex hormone replacement in most older men and women, as proven in the landmark Womens’ Health Initiative and Finnish Oulu randomised controlled trials, and numerous other studies in major centres in North America, UK, Europe, Australia and South Africa, since 1953.

It is a tenet of endocrinology for the past 60 years that all major hormone deficiencies should be replaced permanently and physiologically with the same human hormones, yet there are still those, even medical specialists, who would deny this to those most in need – from middle age onwards, especially women. At least some of these specialists have the honesty to disclose that they are well paid by drug compnies to be advocates and trialists for the wannabe designer drugs to supplant the old.

Recognition of appropriate measured low cost HRT and the other proven listed supplements for all aging people would of course rob the drug industry of perhaps 90% of it’s market for it’s wannabe designer substitutes that the FDA allows to be marketed prematurely until enough people die of their complications or shortcomings.

In fact, while no study shows that any modern drug for common chronic degenerative disease prevention does any overall - mutidisease- good, reduces all-cause mortality, those who promote and practice such published truth – that the old is better - are threatened with prosecution.

Categories: Alzheimer's · HRT · cancer · diabetes prevention · osteoporosis · overweight prevention · supplements
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SOUNDING BOARD: IS ROUTINE HIGH-TECH SCREENING JUSTIFIED IN PEOPLE WITHOUT INCREASED RISK?

April 20, 2008 · 3 Comments

A new Dutch paper at a current Breast cancer BRCA congress in Berlin is reported by the BBC as showing that by 2006, “deaths fell by 30% in those women who had screening mammography in their late seventies” ; http://news.bbc.co.uk/go/em/-/1/hi/health/7352483.stm And From New York, “Screening mammography in elderly patients beneficial” - but no actual benefits to the patients are disclosed, unless one considers surgery without symptoms or disease beneficial to the patient rather than the service provider. http://www.eurekalert.org/pub_releases/2008-04/arrs-smi041108.php.

Mammography is by definition diagnostic not screening if there is already a clinical reason for mammography ie a palpable lump worrying the patient or doctor. Screening, like surgery, is surely by definition justified only if it offers some material benefit to the patient?

But do these (reports published without results to see, in studies, not randomised controlled trials) justify doing screening mammography SMG on all postmenopausal women not at known risk ie who do not have/ have never had any risk factors including on regular manual palpation and family history?
What difference does it make if one simply waits till the elderly woman has a palpable ie still relatively small lump picked up (if ever) at (her) routine (monthly) (self)exam, and a simple non-disfiguring excision done?

It is common cause that all common cancer is less aggressive in the elderly and is rarely the cause of death or disability. http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Breast_Cancer_Less_Aggressive_in_Elderly_Women.asp ; http://www.accessibility.com.au/news/noncancer-deaths-more-common-among-breast-cancer-survivors

All Health Authorities advocate regular (~annual) SMG at least on women 50- 69years , with the upper limit being extended to 75years in some countries. Authorities & governments would – such screening means huge sales, jobs , taxes, profits, kudos.

Since BRCA is the commonest cancer in non-smoking better-off women,the pros and cons of presymptomatic diagnosis is an enormously emotive topic - quite apart from the toasted breast sandwich involved.

But the perennial question remains. Is fear, and the widespread availability of expensive high-tech screening, being used to promote the giant profitable screening industry - does high-tech detection of silent asymptomatic breast, colon or pelvic cancer actual give long-term benefit to patients ? when many such silent cancers are present at death without every having caused symptoms, impairment or disease.

The USA Government health authorities in 2007 show that despite policy promoting SMG, the rates of SMG have fallen in 2000 - 2005. Is this negligence, or common sense?http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5603a1.htm

THOSE IN FAVOUR SAY AYE!
Automated high-tech screening mammography is passionately advocated by service providers, who favour all types of high-tech universal screening:

in the Swedish Two-County Trial of SMG, in “ 77 080 women randomised to an invitation to SMG and 55 985 to no invitation, . there was a significant 31% reduction in breast cancer mortality in the invited group . There was 12% non significant increase in deaths from other causes among breast cancer cases in the invited group (95% CI 0.96-1.31; p=0.14). A conservative estimation gave a significant 13% reduction (RR 0.87, 95% CI 0.78-0.97; p=0.01) reduction in deaths from all causes.
<a href=”http://”>

  • http://www.ingentaconnect.com/content/rsm/jms/2002/00000009/00000004/art00004

  • In the 14 year follow-up from the Edinburgh randomised trial of breast-cancer screening in 54600 women, unadjusted results showed a difference of just 13% in breast-cancer mortality rates between the intervention and control groups (156 deaths [5.18 per 10,000] vs 167 [6.04 per 10,000]; rate ratio 0.87 [95% CI 0.70-1.06]).. http://www.ncbi.nlm.nih.gov/pubmed/10371567

    The 16-year mortality from breast cancer in the UK non-randomised study of Early Detection of Breast Cancer set up in 1979 in England and Scotland recruited women aged 45-64 years. Breast-cancer mortality was 27% lower in the two screening centres combined than in the comparison centres. No reduction in mortality in the two breast self-examination centres combined was seen The results support those from randomised trials in Edinburgh and elsewhere, and show that a reduction in breast-cancer mortality resulting from screening can be achieved in the UK. There was no evidence of less benefit in women aged 45-46 years at the start of screening; the effect of screening in this age-group begins to emerge after 3-4 years. . <a href=”http://”>http://www.ncbi.nlm.nih.gov/pubmed/10371568

    THOSE AGAINST generally stay mum- it’s dangerous to go against populist opinion that is driven by major financial interests..
    But in 2006, Gøtzsche PC and Nielsen at the Nordic Centre analysed all randomised controlled trials, and controversially questioned “whether mammography screening does more good than harm. The two trials (Canadian) with adequate randomisation did not find an effect of screening (RR risk ratio 1.1) on cancer mortality, including breast cancer after 10 years, or on all-cause mortality, after 13 years. Breast cancer mortality was an unreliable outcome that was biased in favour of screening, mainly because of differential misclassification of cause of death. Numbers were significantly 30% larger in the screened groups. CONCLUSIONS: Screening likely reduces breast cancer mortality. But based on the risk level of women in these trials, the absolute risk reduction was 0.05%. Screening also leads to over-diagnosis and over-treatment, with an estimated 30% increase in eg lumpectomies, mastectomies and radiotherapy, or an absolute risk increase of 0.5%. This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged but 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily. It is thus not clear whether screening does more good than harm. Women invited to screening should be fully informed of both benefits and harms.” http://www.cochrane.org/reviews/en/ab001877.html

    THE CANADIAN TRIALS:
    Comparing screening mammography alone versus manual examination (usual care) alone from 1980-85,
    Tony Miller et al in the Canadian National Breast Screening Study of women followed through for 13 years showed similar breast cancer death rates and similar survival rates whether by manual breast exam or SMG:
    In two groups each of 19700 aged 50-59years at outset, http://jnci.oxfordjournals.org/cgi/content/short/92/18/1490 . The average lead time for the mammography plus physical examination group has been estimated to be 3.6 years (95% CI = 2.7–5.5) and that for the physical examination-only group was 1.5 years (95% CI = 1.0–3.3 years); therefore, the lead time gained by mammography was, on average, 2.1 years. All-cause Mortality was similar at 0.35%pa and breast cancer mortality 1/7th of that at 0.05%pa
    (c/f .01% in Finland , with no benefit from SMG – Antilla ea 2008 http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18226204), while invasive BRCA incidence was 0.23%pa ie the BRCA mortality rate from invasive breast cancer irelative to those who got invasive BRCA was about 22%pa. .
    In the two cohorts each of 25215 age 40-49yrs at outset
    , - http://www.annals.org/cgi/content/full/137/5_Part_1/305 ,
    all-cause mortality was 0.1%pa and breast cancer mortality 1/3rd of that at 0.034%pa were almost identical comparing the two group while invasive BRCA incidence was 0.19%pa; ie the BRCA mortality rate from invasive breast cancer relative to those who got invasive BRCA was about 22%pa.
    In this study, only slightly more BRCA were detected by mammography alone or by manual exam alone than by usual care; but twice as many BRCA ie 0.04% pa- were detected by combination of SMG plus physical exam -. Thus screening mammography offers only marginally more detection than manual exam, and no better survival..”

    Analysis of studies of results of high-tech ie technology-based screening for lung; prostate, colon, uterine and ovarian cancers, cholesterol- lipidemia or cardiovascular disease similarly gives no strong evidence favouring widespread screening in asymptomatic people without relevant symptoms or risk factors. It is common cause that, in those without strong family history of common major degenerative disease, of premature deaths and disabling diseases, preventable smoking, obesity- diabetes, vascular disease, dementia and fractures affect probably tenfold more people than preventable cancers.

    From the published data, there is just not enough evidence to justify that either the state, or medical schemes, should pay for routine high-tech screening for any disease in those who do not have risk factors or symptoms.

    Instead, all patients and doctors should be compelled by Regulators, employers and medical schemes to regularly monitor blood-pressure, dental and eye health, BMI and waist girth, since early simple management of any abnormalities have proven major longterm benefits and cost-savings, without any of the costly risks of eg false-positive high-tech screening, or of waiting for disease – obesity, vascular accident, blindness etc - to present. Changing peoples’
    lifestyle, exercise patterns is not easy, but huge benefits accrue therefrom.

    So perhaps the compromise, to meet the concern of the hawks, is that since (unlike prostates), removal of small suspicious colon polyps and breast lumps is easy, all at low risk should be accepted for breast/ colon imaging once in midlife; and if this screening be negative, left in peace unless something develops or eg the woman or man starts on HRT.

    By contrasr: Only Disease Pays the Disease Industry; so is it ethical to allow people to wilfully continue destroying their health with alcohol, smoking, overweight, neglect of hypertension, then allow them to rely on their health scheme/ insurer (which may be the State) to repair them at enormous cost, support them if disabled, when major disease breaks out?

    And is it ethical for low-risk asymptomatic patients who can afford it to be encouraged to have futile repeated high-tech screening? http://news.sky.com/skynews/article/0,,91168-1269537,00.html
    http://www.webmd.com/breast-cancer/news/20080304/new-feedback-on-high-tech-cancer-screen</a>
    When the only interventions from young age that have been proven to reduce by about 50% all-cause mortality from the common major chronic degenerative diseases of aging are:
    Regular exercise; no smoking; avoiding overweight, maintaining normal bloodpressure;
    Fish oil a few grams a day;
    And other essential multisupplements in balance that deplete in the food chain and with aging and pollution
    ie all vitamins , minerals and biologicals- (human, other species’ and plant, and appropriate HRT (thyroid, sex hormone, cortisol replacement).

    Categories: HRT · cancer · overweight prevention · supplements
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    THE MULTI - TRILLION-DOLLAR WAR AND IT’S COST TO HEALTH

    April 20, 2008 · No Comments

    next time you are at a Mall bookshop, browse through if not buy Joseph Stiglitz & Linda Blimes’ new book The Three Trillion Dollar War.
    see The Times Online article review.

    It details why greedy leaders ancient and modern go to war - for the massive profit, at the expense of others.

    The three trillion dollar cost so far of Bush’s War on Terrorism (the cost calculated by leading economists) is just the cost to Americans,
    excluding many times that cost for the rest of the world affected by the permanent state of war and resultant rampant inflation, further global warming and burn-up of commodities.

    Never mind the hundreds of thousands killed or maimed in the conflict, and incalculable damage to health in the region, the ripples hugely aggravate poverty, mental ill-health and starvation in the rest of the world, as aggression and counter-aggression racks up the stakes between all hawkish leaders like Bush, Blair, Putin, Mugabe, Zuma at al. .

    As Stiglitz & co say, one can speculate how such untold war costs could have been spent on peaceful developments everywhere, no matter that USA families - who earn an average of $70 000 a year - can afford it, while the majority of earthlings- as in South Africa - survive or die on less than a dollar a day, often below $1000 per family per year.

    But who cares about lives and health lost, the doubling in basic food costs when war is untold billion-dollar contracts to presidents and their business cronies including medical suppliers, as even South Africa experiences.. We wish we could forsee imminent closure better than Margaret Attwood’s Oryx and Craik…

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    more bisphosphonate, statin complications:

    March 19, 2008 · 1 Comment

    note the latest designer drug complications-

    severe diffuse pain from statins and biphosphonates,

    interstitial lung disease, and tendon rupture, from statin:

    FDA ALERT [1/7/2008]: ” FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.”
    read on at http://www.fda.gov/CDER/drug/InfoSheets/HCP/bisphosphonatesHCP.htm

    CONCERNS ABOUT STATINS: COMPLICATIONS AND SIDE EFFECTS: TreatmentUpdate 150 Volume 17 Issue 4 2005 June/July http://www.catie.ca/tu.nsf/acdff2c60dab4741852571b60051c9fe/d5b21cf52ec5187785257066005ce726!OpenDocument Currently available statins include the following:
    atorvastatin (Lipitor)
    fluvastatin (Lescor and Lescor XL)
    pravastatin (Pravachol)
    rosuvastatin (Crestor)
    simvastatin (Zocor)
    “Statin safety controversy
    The safety of statins has become controversial in recent years. In 2001, another powerful statin, cerivastatin (Baycol, Lipobay), had to be withdrawn from sale because, particularly at higher doses, it was linked to the development of muscle weakness and kidney damage. The manufacturer of cerivastatin, Bayer, was subsequently listed as a defendant in 14,700 lawsuits around the world. Nearly 3,000 of these have been settled at a cost of $1.3 billion US.

    “Crestor was licensed in high-income countries over the past couple of years in this environment of lawsuits and heightened safety concerns. As a result, perhaps its side effects have come under more scrutiny than expected.

    “An American consumer advocacy group, Public Citizen, has criticized regulatory authorities in that country for the approval of Crestor. Moreover, Public Citizen has asked the Food and Drug Administration (FDA) to ban the sale of Crestor because of concerns about its safety. However, the FDA has refused to do so.

    Warnings from regulatory agencies
    In 2004, several regulatory agencies in Canada and the European Union sent letters to physicians warning them to begin therapy with Crestor at a low dose of the drug and reminding them about possible side effects. Last year, Canada’s Federal Health Ministry also sent an advisory to patients asking them to review the use of Crestor with their doctors. In July 2005, Health Canada has issued yet another advisory to patients related to the use of statins, warning them about health conditions that may make users more susceptible to side effects from statins (a report on this appears later in this issue of TreatmentUpdate).
    http://www.arc.org.uk/news/article/18492474 Statin use linked to tendon complications. Statins, popularly prescribed treatments for lowering cholesterol, have been linked to tendon complications, according to a new study published in the journal Arthritis Care & Research.

    A team of French scientists found that although very rare, there was evidence of a link between statins, which are widely used and have been demonstrated to be safe in large clinical trials, and musculoskeletal complications, such as tendon impairment.

    Studying patient records from the Rouen University Hospital database between 1990 and 2005, 4,597 side effects were associated with statins, most of which were extremely mild.

    Approximately two per cent of these, identified in 96 cases, were attributed to tendon complications. Symptoms usually occurred within eight months of beginning statin therapy and included tendonitis and occasionally ruptured tendons.

    “Our study suggests that regular tendinous clinical examination may be required in statin-treated patients, particularly during the first year following statin therapy initiation,” the authors reported.

    Although the researchers did not know how statins are linked to tendon injury, they suggested that blocking cholesterol synthesis could reduce the cholesterol content of tendon cell membranes, making them less stable.

    Title MHRA: class side-effects of statins
    Date Published 04/02/2008 http://www.nelm.nhs.uk/Record%20Viewing/vR.aspx?id=589805
    Reporter initials Nicola Pocock Hospital Pharmacist
    Source MHRA Drug Safety Update; February 2008
    ” The February 2008 issue of ‘Drug Safety Update’ from the MHRA notes that product information for statins is being updated to reflect a number of different side-effects which appear to be a class-effect of these medicines. The following prescribing advice is given:

    • Patients should be made aware that treatment with any statin may sometimes be associated with depression, sleep disturbances, memory loss, and sexual dysfunction

    • Statins may very rarely be associated with interstitial lung disease. Patients should seek help from their doctor if they develop presenting features of interstitial lung disease such as dyspnoea, non-productive cough, and deterioration in general health (e.g., fatigue, weight loss, and fever)”

    note: the MHRA list convenently ignores the insidious muscle damage- myopathy- kidney- liver damage that statins cause”.

    These heavily prescribed drugs are never needed for mild-to-moderate lipidemia, or for osteoporosis, since there are better safer natural long-proven drugs.
    ndb

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    Pioneering Midwife Touts Orgasmic birthing

    March 13, 2008 · No Comments

    Dr Joe Mercola gives praise where it is due:

      http://articles.mercola.com:80/sites/articles/archive/2008/3/13/pioneering-midwife-touts-quot-orgasmic-birth-quot.aspx

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